Abatacept Versus Adalimumab Head-to-Head

Last updated: January 3, 2014
Sponsor: Bristol-Myers Squibb
Overall Status: Completed

Phase

3

Condition

Rheumatoid Arthritis

Arthritis And Arthritic Pain

Joint Injuries

Treatment

N/A

Clinical Study ID

NCT00929864
IM101-235
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is demonstrate that subcutaneous abatacept is non-inferior (no worse than) to subcutaneous adalimumab in the treatment of subjects with rheumatoid arthritis who are biologic naive

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Moderate to severe Rheumatoid arthritis (RA) according to American College ofRheumatology (ACR) criteria

  • Methotrexate failure

  • Naive to RA biologics

  • ≤5 years duration of disease

  • Disease Activity Score-28 C-reactive protein (DAS28 CRP) ≥ 3.2

  • Willingness to self-inject subcutaneous (SC) drug

Exclusion

Exclusion Criteria:

  • Previous or current medical conditions that are warnings against the use of tumornecrosis factor (TNF)-blocking agents

  • History of active or chronic hepatitis

  • Cancer in the last 5 years

  • History of severe chronic or recurrent bacterial or viral infections

  • Risk of tuberculosis

  • Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic,Gastro-intestinal, pulmonary, cardiac, neurologic, or cerebral disease

Study Design

Total Participants: 869
Study Start date:
October 01, 2009
Estimated Completion Date:
November 30, 2012

Connect with a study center

  • Local Institution

    Ciudad Autonoma, Buenos Aires CP1425A WC
    Argentina

    Site Not Available

  • Local Institution

    Ciudad Autonoma D Buenos Aires, Buenos Aires 1055
    Argentina

    Site Not Available

  • Local Institution

    Ciudad Autonoma De Beunos Aire, Buenos Aires 1431
    Argentina

    Site Not Available

  • Local Institution

    Ciudad Autonoma De Buenos Aire, Buenos Aires 1015
    Argentina

    Site Not Available

  • Local Institution

    Quilmes, Buenos Aires 1878
    Argentina

    Site Not Available

  • Local Institution

    Cordoba, Crd, Cordoba X5016KEH
    Argentina

    Site Not Available

  • Local Institution

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • Local Institution

    San Miguel, Tucuman 4000
    Argentina

    Site Not Available

  • Local Institution

    San Miguel De Tucuman, Tucuman 4000
    Argentina

    Site Not Available

  • Local Institution

    Buenos Aires, C1280AEB
    Argentina

    Site Not Available

  • Local Institution

    Cordoba, 5000
    Argentina

    Site Not Available

  • Local Institution

    San Juan, 5400
    Argentina

    Site Not Available

  • Local Institution

    Tucuman, 4000
    Argentina

    Site Not Available

  • Local Institution

    Edmonton, Alberta T6G 2S2
    Canada

    Site Not Available

  • Local Institution

    Vancouver, British Columbia V5Z 1L7
    Canada

    Site Not Available

  • Local Institution

    Winnipeg, Manitoba R3A 1M3
    Canada

    Site Not Available

  • Local Institution

    Hamilton, Ontario L8N 1Y2
    Canada

    Site Not Available

  • Local Institution

    Trois-Rivieres, Quebec G8Z 1Y2
    Canada

    Site Not Available

  • Local Institution

    Quebec, G1V 3M7
    Canada

    Site Not Available

  • Local Institution

    Santiago De Chile, Metropolitana 0
    Chile

    Site Not Available

  • Local Institution

    Santiago, Providencia
    Chile

    Site Not Available

  • Local Institution

    Bellavista, Callao 2
    Peru

    Site Not Available

  • Local Institution

    Lima, LIMA 11
    Peru

    Site Not Available

  • Rheumatology Associates, Pc

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • University Of Alabama At Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Rheumatology Associates Of North Alabama, P.C.

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Clinical And Translational Research Center Of Alabama, Pc

    Tuscaloosa, Alabama 35406
    United States

    Site Not Available

  • Novara Clinical Research

    Mesa, Arizona 85206
    United States

    Site Not Available

  • Sun Valley Arthritis Center, Ltd.

    Peoria, Arizona 85381
    United States

    Site Not Available

  • Catalina Pointe Clinical Research, Inc.

    Tucson, Arizona 85704
    United States

    Site Not Available

  • Mercy Clinic Hot Springs Communities

    Hot Springs, Arkansas 71913
    United States

    Site Not Available

  • Talbert Medical Group

    Huntington Beach, California 92646
    United States

    Site Not Available

  • Allergy & Rheumatology Medical Clinic, Inc.

    La Jolla, California 92037
    United States

    Site Not Available

  • Loma Linda University Faculty Medical Offices

    Loma Linda, California 92354
    United States

    Site Not Available

  • Valerius Med Group & Res Ctr Of Greater Long Beach, Inc.

    Long Beach, California 90806
    United States

    Site Not Available

  • Ucla

    Los Angeles, California 90095
    United States

    Site Not Available

  • Rheumatology Associates

    North Hollywood, California 91607
    United States

    Site Not Available

  • Irene Y. Tong

    Pasadena, California 91107
    United States

    Site Not Available

  • San Diego Arthritis Medical Clinic

    San Diego, California 92108
    United States

    Site Not Available

  • Pacific Arthritis Center

    Santa Maria, California 93454
    United States

    Site Not Available

  • Drs. Goldin, Nies, Klashman & Eng

    Torrance, California 90505
    United States

    Site Not Available

  • Healthcare Partners Medical Group

    Torrance, California 90503
    United States

    Site Not Available

  • Robin K. Dore, Md Inc.

    Tustin, California 92780
    United States

    Site Not Available

  • Inland Rheumatology & Osteoporosis Medical Group

    Upland, California 91786
    United States

    Site Not Available

  • Arthritis Research Consultants, Llc

    Bridgeport, Connecticut 06606
    United States

    Site Not Available

  • Arthritis And Rheumatic Disease Specialties

    Aventura, Florida 33180
    United States

    Site Not Available

  • Center For Rheumatology, Immunology And Arthritis

    Ft. Lauderdale, Florida 33334
    United States

    Site Not Available

  • University Of Florida College Of Medicine At Jacksonville

    Gainesville, Florida 32610
    United States

    Site Not Available

  • University Of Florida College Of Medicine At Jacksonville

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • Center For Arthritis And Rheumatic Diseases

    Miami, Florida 33173
    United States

    Site Not Available

  • Arthritis & Osteoporosis Treatment Center, Pa

    Orange Park, Florida 32073
    United States

    Site Not Available

  • Arthritis Research Of Florida, Inc.

    Palm Harbor, Florida 34684
    United States

    Site Not Available

  • West Florida Medical Center Clinic

    Pensacola, Florida 32514
    United States

    Site Not Available

  • Sarasota Arthritis Research Center

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Miami Research Associates

    South Miami, Florida 33143
    United States

    Site Not Available

  • West Broward Rheumatology Associates

    Tamarac, Florida 33321
    United States

    Site Not Available

  • Tampa Medical Group, Pa

    Tampa, Florida 33614
    United States

    Site Not Available

  • Lovelace Scientific Resources, Inc

    Venice, Florida 34292
    United States

    Site Not Available

  • Florida Medical Clinic, Pa

    Zephyrhills, Florida 33542
    United States

    Site Not Available

  • Arthritis & Rheumatology Of Georgia

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Laureate Clinical Research Group

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Arthritis Center Of North Georgia

    Gainesville, Georgia 30501
    United States

    Site Not Available

  • St. Luke'S Clinic - Rheumatology

    Boise, Idaho 83702
    United States

    Site Not Available

  • Coeur D'Alene Arthrit Clin

    Coeur D Alene, Idaho 83814
    United States

    Site Not Available

  • Quincy Medical Group

    Quincy, Illinois 62301
    United States

    Site Not Available

  • Quad City Rheumatology

    Rock Island, Illinois 61201
    United States

    Site Not Available

  • Rockford Orthopedic Associates, Ltd.

    Rockford, Illinois 61107
    United States

    Site Not Available

  • Physicians Clinic Of Iowa

    Cedar Rapids, Iowa 52401
    United States

    Site Not Available

  • Center For Arthritis And Osteoporosis

    Elizabethtown, Kentucky 42701
    United States

    Site Not Available

  • Bluegrass Community Research, Inc.

    Lexington, Kentucky 40504
    United States

    Site Not Available

  • Rheumatology Associates

    Louisville, Kentucky 40218
    United States

    Site Not Available

  • Ochsner Health Center

    Raton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Klein And Associates, M.D., Pa

    Cumberland, Maryland 21502
    United States

    Site Not Available

  • Klein And Associates, M.D., Pa

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • The Center For Rheumatology And Bone Research

    Wheaton, Maryland 20902
    United States

    Site Not Available

  • Brigham And Women'S Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Mansfield Health Center

    Mansfield, Massachusetts 02048
    United States

    Site Not Available

  • Hampden County Physicians Associate

    Springfield, Massachusetts 01103
    United States

    Site Not Available

  • Umass Memorial Medical Center

    Worcester, Massachusetts 01605
    United States

    Site Not Available

  • Associated Internal Medicine Specialists

    Battle Creek, Michigan 49015
    United States

    Site Not Available

  • Rheumatology Pc

    Kalamazoo, Michigan 49009
    United States

    Site Not Available

  • Shores Rheumatology, P. C.

    St. Clair Shores, Michigan 48081
    United States

    Site Not Available

  • St. Paul Rheumatology, P.A.

    Eagan, Minnesota 55121
    United States

    Site Not Available

  • Arthritis And Osteoporosis Treatment And Research Center

    Flowood, Mississippi 39232
    United States

    Site Not Available

  • Arthritis Associates Of Mississippi

    Jackson, Mississippi 39202
    United States

    Site Not Available

  • Physician Groups, Lc Dba

    St.Louis, Missouri 63131
    United States

    Site Not Available

  • Physician Research Collaboration, Llc

    Lincoln, Nebraska 68516
    United States

    Site Not Available

  • Arthritis Center Of Reno

    Reno, Nevada 89502
    United States

    Site Not Available

  • Seacoast Arthritis And Osteoporosis Center

    Dover, New Hampshire 03820
    United States

    Site Not Available

  • Nashua Rheumatology

    Nashua, New Hampshire 03060
    United States

    Site Not Available

  • Albuquerque Rehabilitation & Rheumatology Pc

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Arthritis And Osteoporosis Associates Of New Mexico

    Las Cruces, New Mexico 88011
    United States

    Site Not Available

  • Arthritis & Osteoporosis Medical Associates, Pllc

    Brooklyn, New York 11201
    United States

    Site Not Available

  • North Shore Lij Health System

    Lake Success, New York 11042
    United States

    Site Not Available

  • Winthrop University Hospital

    Mineola, New York 11501
    United States

    Site Not Available

  • Nyu Hospitl For Joint Diseases

    New York, New York 10003
    United States

    Site Not Available

  • Rheumatology Associates Of Long Island

    Smithtown, New York 11787
    United States

    Site Not Available

  • Arthritis Health Associates

    Syracuse, New York 13210
    United States

    Site Not Available

  • Asheville Rheumatology & Osteoporosis Research Asso P. A.

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • Arthritis & Osteoporosis Consultants Of The Carolinas

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Drs. Barada, Harrell, Toohey, Belhorn And Klett

    Durham, North Carolina 27704
    United States

    Site Not Available

  • Carolina Bone & Joint, Pa

    Monroe, North Carolina 28112
    United States

    Site Not Available

  • Carolina Pharmaceutical Research

    Statesville, North Carolina 28625
    United States

    Site Not Available

  • Cincinnati Rheumatic Disease Study Group

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • David R. Mandel, Md, Inc.

    Mayfield Village, Ohio 44143
    United States

    Site Not Available

  • Clinical Research Source Inc.

    Perrysburg, Ohio 43551
    United States

    Site Not Available

  • Health Research Institute

    Oklahoma City, Oklahoma 73109
    United States

    Site Not Available

  • Health Research Of Oklahoma

    Oklahoma City, Oklahoma 73103
    United States

    Site Not Available

  • Lynn Health Sciences Institute

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Healthcare Research Consultants

    Tulsa, Oklahoma 74135
    United States

    Site Not Available

  • Providence Arthritis Center

    Portland, Oregon 97213
    United States

    Site Not Available

  • East Penn Rheumatology Associates, P.C.

    Bethlehem, Pennsylvania 18015
    United States

    Site Not Available

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Elite Medical Research, Inc.

    Sellersville, Pennsylvania 18960
    United States

    Site Not Available

  • Allegheny North Arthritis Center

    Wexford, Pennsylvania 15090
    United States

    Site Not Available

  • Clinical Research Center Of Reading, Llp

    Wyomissing, Pennsylvania 19610
    United States

    Site Not Available

  • Low Country Rheumatology, Pa

    Charleston, South Carolina 29406
    United States

    Site Not Available

  • Columbia Arthritis Center, P.A.

    Columbia, South Carolina 29204
    United States

    Site Not Available

  • The Carolina Center For Rheumatology & Arthritis Care, Pa

    Rock Hill, South Carolina 29732
    United States

    Site Not Available

  • Comprehensive Rheumatology Care

    Henderson, Tennessee 37075
    United States

    Site Not Available

  • Arthritis Associates, Pllc

    Hixson, Tennessee 37343
    United States

    Site Not Available

  • Rheumatology Consultants Pllc

    Knoxville, Tennessee 37909
    United States

    Site Not Available

  • Vanderbilt University

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Lovelace Scientific Resources, Inc.

    Austin, Texas 78758
    United States

    Site Not Available

  • Arthritis Centers Of Texas

    Dallas, Texas 75246
    United States

    Site Not Available

  • Corona Research Clinical Studies

    El Paso, Texas 79904
    United States

    Site Not Available

  • Rheumatic Disease Clinical Research Center, Llc

    Houston, Texas 77004
    United States

    Site Not Available

  • Arthritis Clinic Of Northern Virginia, P.C.

    Arlington, Virginia 22205
    United States

    Site Not Available

  • Center For Arthritis & Rheumatic Diseases, Pc

    Chesapeake, Virginia 23320
    United States

    Site Not Available

  • Northern Virginia Center For Arthritis

    Reston, Virginia 20190
    United States

    Site Not Available

  • Virginia Mason Medical Center

    Seattle, Washington 98101
    United States

    Site Not Available

  • Rockwood Research Center

    Spokane, Washington 99202
    United States

    Site Not Available

  • Mountain State Clinical Research

    Clarksburg, West Virginia 26301
    United States

    Site Not Available

  • Rheumatic Disease Center

    Glendale, Wisconsin 53217
    United States

    Site Not Available

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